Alucent Medical Receives FDA Approval to Begin Clinical Trials of Novel Therapy for Vascular Disease

SALT LAKE CITY–(BUSINESS WIRE)–Alucent Medical, Inc. has announced that it has received U.S. Food and Drug Administration (FDA) approval to begin Phase 1 human clinical studies of Natural Vascular Scaffolding (NVS)™, its novel combination drug/device therapy for the treatment of peripheral vascular disease (PVD). Alucent Medical, Inc. is a new company formed to develop and market this novel photo-activated drug therapy, and is owned by the research and development arm of Avera Health, an integrated, multi-state health system based in Sioux Falls, S.D.

“NVS has the potential to leap-frog current treatments for peripheral vascular disease”

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“The promise of this novel therapy is extraordinary. We believe NVS could deliver quantum advancement in the treatment of peripheral vascular disease with the potential of eliminating vascular stents for this condition,” said James Corbett, who is chairman of the board of Alucent and has 30 years of experience in the medical device field.

The existing standard of care for peripheral vascular disease utilizes percutaneous balloon angioplasty (PTA), in which balloons are coated with known antiproliferative drugs such as paclitaxel, and metallic stents. These treatments often result in recurrence of the target lesion and the need for retreatment. NVS, in contrast, is a novel photo-activated drug therapy designed to build natural scaffolding to keep the vessel open durably, possibly replacing the need for an implanted stent.

“NVS has the potential to leap-frog current treatments for peripheral vascular disease,” said Myles Greenberg, MD, president and CEO of Alucent Medical, Inc.

Phase I studies of NVS will commence this summer at three locations across the U.S. The principal investigator for the Alucent-sponsored Phase I trial of NVS therapy in PVD is Gary Ansel, MD, FACC, System Medical Chief, Vascular Program, OhioHealth, Columbus, Ohio.

“We are thrilled that this innovation has reached the point of U.S. clinical trials. We believe it will improve quality of life for many patients, and this ultimately is the Avera mission. We’ve been behind it by supporting and investing in this research, and it is extremely exciting to reach this milestone,” said Fred Slunecka, Chief Operating Officer for Avera Health.

NVS was developed by Avera scientists, and Avera has invested more than $20 million toward its development. The initial discovery team was led by founder Ron Utecht, PhD, a former professor of chemistry and biochemistry at South Dakota State University. Utecht and Avera hold approximately 20 patents for NVS.

About Avera Health

The Avera Health system, based in Sioux Falls, S.D., has over 17,000 employees and physicians, serving more than 300 locations and 100 communities in a five-state region. Our ministry, our people and our superior value distinguish Avera. We carry on the health care legacy of the Benedictine and Presentation Sisters, delivering care in an environment guided by our values of compassion, hospitality and stewardship. For more information about Avera, see our website at Avera.org.

About Alucent Medical, Inc.

Alucent Medical, Inc. is a privately held biotechnology company headquartered in Salt Lake City, Utah. Alucent Medical was founded by Avera Health to develop and market Natural Vascular Scaffolding (NVS), a novel combination drug-device product for the treatment of patients suffering from peripheral vascular disease. Alucent Medical is currently conducting U.S. Phase 1 human clinical trials. Visit alucentmedical.com for more information.